Actinic Keratosis

8
Pipeline Programs
4
Companies
6
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
3
2
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

U
DICLOFENAC SODIUMApproved
diclofenac sodium
Unknown Company
ophthalmic1998
U
PENNSAIDApproved
diclofenac sodium
Unknown Company
topical2009

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Teva
TevaIsrael - Petach Tikva
2 programs
2
Diclofenac sodiumPhase 31 trial
Imiquimod Cream, 3.75%Phase 31 trial
Active Trials
NCT02611804Completed492Est. Aug 2016
NCT01686152Completed589Est. Aug 2013
PharmaEssentia
PharmaEssentiaMA - Burlington
1 program
1
KX01 ointment 1%Phase 31 trial
Active Trials
NCT05231044CompletedEst. Nov 2023
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
2 programs
2
Imiquimod 3.75% CreamPhase 21 trial
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combinationPhase 21 trial
Active Trials
NCT03914417CompletedEst. Apr 2015
NCT03122457CompletedEst. Jul 2018
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
1
SOR007Phase 21 trial
Active Trials
NCT03083470CompletedEst. Mar 2018

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
PharmaEssentiaKX01 ointment 1%
TevaDiclofenac sodium
TevaImiquimod Cream, 3.75%
Biotest PharmaceuticalsSOR007
Bausch Healthlidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination
Bausch HealthImiquimod 3.75% Cream

Clinical Trials (6)

Total enrollment: 1,081 patients across 6 trials

NCT05231044PharmaEssentiaKX01 ointment 1%

A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp

Start: Dec 2021Est. completion: Nov 2023
Phase 3Completed
NCT02611804TevaDiclofenac sodium

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp

Start: Oct 2015Est. completion: Aug 2016492 patients
Phase 3Completed
NCT01686152TevaImiquimod Cream, 3.75%

Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis

Start: Sep 2012Est. completion: Aug 2013589 patients
Phase 3Completed
NCT03083470Biotest PharmaceuticalsSOR007

Study of SOR007 Ointment for Actinic Keratosis

Start: May 2017Est. completion: Mar 2018
Phase 2Completed
NCT03122457Bausch Healthlidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination

Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide

Start: Jan 2017Est. completion: Jul 2018
Phase 2Completed
NCT03914417Bausch HealthImiquimod 3.75% Cream

Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream

Start: Jan 2013Est. completion: Apr 2015
Phase 2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
4 companies competing in this space